FDA 510(k) Applications for Medical Device Product Code "MFX"
(Vessel Guard Or Cover, To Facilitate Revision Surgeries)

FDA 510(k) Number Applicant Device Name Decision Date
K061727 W.L. GORE & ASSOCIATES,INC GORE PRECLUDE VESSEL GUARD 08/07/2006
K960532 W.L. GORE & ASSOCIATES,INC PRECLUDE IMA SLEEVE 05/23/1996


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